Technology | March 20, 2014

FDA Approves Piramal Imaging's PET Imaging Tracer for Beta-Amyloid Plaques

Approval expands availability of Alzheimer's diagnostic imaging agent

Neuraceq, florbetaben, F18, F-18, Piramal, alzheimer's

A comparison of brain images showing positive and negative scans for the presence of beta-amyloid plaques using the Neuraceq (florbetaben F-18) radiotracer.

Neuraceq, florbetaben, F18, F-18, Piramal, alzheimer's

March 20, 2014 — The U.S. Food and Drug Administration (FDA) approved a third beta-amyloid plaque positron emission tomography (PET) imaging radiotracer to identify Alzheimer’s disease. The FDA’s approval of Piramal Imaging’s Neuraceq (florbetaben F-18 injection) comes four weeks after receiving marketing authorization in Europe. 

It is the third radiotracer to gain FDA clearance for beta amyloid plaque imaging. Last October, the FDA-cleared Vizamyl (flutemetamol F-18 injection) was developed for GE Healthcare by Medi-Physics Inc. The first agent to gain approval was Amyvid (florbetapir F-18 Injection) in April 2012. Amyvid was developed by Eli Lilly & Co. and Avid Radiopharmaceuticals Inc. Prior to these agents, the only clear diagnosis of Alzheimer’s was by post-mortem autopsy. 
Neuraceq is indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.
There are an estimated 7.7 million new cases of dementia each year worldwide.[1] Alzheimer's disease accounts for 60-80 percent of all dementia diagnoses.[2] However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30 percent of cases.[3]
The Centers for Medicare and Medicaid Services (CMS) declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programs. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.
"Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis," said Ludger Dinkelborg, director of the board, Piramal Imaging. "For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path."
"The FDA's approval of Neuraceq is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally," said Swati Piramal, vice chairperson, Piramal Enterprises Ltd. "The rising prevalence of Alzheimer's disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and helps improve patient outcomes."
The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.
Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.
Neuraceq Indications and Use
A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.
Neuraceq is an adjunct to other diagnostic evaluations.
The FDA limits established for this radiotracer include that a positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. Also, the safety and effectiveness of Neuraceq have not been established for predicting development of dementia or other neurologic conditions or for monitoring responses to therapies.
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 978 Neuraceq administrations were injection/application site erythema (1.7%), injection site irritation (1.2%) and injection site pain (3.9%).
For more information:
1. WHO. Dementia: A public health priority; 2012
?2. Alzheimer's Association. Alzheimer Dement. 2013;9 ?
3. American Psychiatric Association. Practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Second edition. 2007. https://psychiatry (accessed20 Dec 2011)

Related Content

PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer Patients
News | PET Imaging | August 09, 2018
In metastatic breast cancer, prognosis and treatment is largely influenced by estrogen receptor (ER) expression of the...
Aidoc Receives FDA Clearance for AI Detection of Acute Intracranial Hemorrhage
Technology | Clinical Decision Support | August 08, 2018
Aidoc announced that it was granted U.S. Food and Drug Administration (FDA) clearance for the first product of its...
Novel PET Imaging Method Could Track and Guide Type 1 Diabetes Therapy
News | PET Imaging | August 03, 2018
Researchers have discovered a new nuclear medicine test that could improve care of patients with type 1 diabetes. The...
CT Decision Instrument Reliably Guides Pediatric Blunt Trauma imaging Decisions

This is a four-site prospective observational cohort. Image courtesy of Kirsty Challen, B.Sc., MBCHB, MRES, Ph.D., Lancashire Teaching Hospitals, United Kingdom.

News | Clinical Decision Support | July 18, 2018
A new study finds The Pediatric NEXUS Head Computed Tomography (CT) Decision Instrument (DI) reliably identifies blunt...
Artificial Intelligence Provides Faster, Clearer MRI Scans

A new artificial-intelligence-based approach to image reconstruction, called AUTOMAP, yields higher quality images from less data, reducing radiation doses for CT and PET and shortening scan times for MRI. Shown here are MR images reconstructed from the same data with conventional approaches, at left, and AUTOMAP, at right. Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital

News | Artificial Intelligence | July 17, 2018
A research team with funding from the National Institute for Biomedical Imaging and Bioengineering (NIBIB) has...
Researchers Trace Parkinson’s Damage in the Heart
News | PET Imaging | July 17, 2018
A new way to examine stress and inflammation in the heart will help Parkinson’s researchers test new therapies and...
Siemens Healthineers Announces FDA Clearance of syngo.via VB30 Molecular Imaging Software
Technology | Nuclear Imaging | July 16, 2018
At the 2018 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), June 23-26 in Philadelphia...
iSchemaView Brings RAPID Imaging Platform to Australia and New Zealand
News | Stroke | July 13, 2018
iSchemaView has signed Diagnostic Imaging Australia (DIA) to be the exclusive distributor for the RAPID cerebrovascular...
Neural Analytics Inc. Receives CE Mark for Robotic Ultrasound System
Technology | Ultrasound Imaging | July 03, 2018
Medical robotics company Neural Analytics Inc. announced that it received CE Mark for its NeuralBot System, a robotic...
Overlay Init